[Safety and efficacy of integrated robotic systems for coronary procedures]
Dobrzynska A, Molina Linde JM, Isabel Gómez R, Blasco Amaro JA
Record ID 32018014204
Spanish
Original Title:
Seguridad y eficacia de los sistemas robóticos integrados para la realización de procedimientos coronarios
Authors' objectives:
The objective is to evaluate the safety, effectiveness and efficiency of integrated robotic systems for performing coronary procedures.
Authors' results and conclusions:
Five systematic reviews providing information on the effectiveness and safety of integrated robotic systems for coronary procedures were identified and analyzed, all with critically low quality.
Additionally, nine non-randomized clinical trials with high or moderate risk of bias were examined. In terms of efficacy/effectiveness, five studies reported technical success rates of R ICP, with an average of 85.8 %. The meta-analysis results indicated no significant difference in clinical success rates and total procedure time between R-PCI and M-PCI. Regarding safety, all included studies analyzed safety variables such as major adverse cardiac events (MACE), all-cause mortality, myocardial infarction, stroke, contrast media usage, fluoroscopy time, operator and assistant radiation dose, and patient radiation dose.
The meta-analysis showed no significant differences between R-PCI and M-PCI groups in terms of MACE, all-cause mortality, and myocardial infarction. It revealed a significant reduction in radiation exposure, fluoroscopy time, and contrast media usage during R-PCI procedures compared to M-PCI. However, these differences in fluoroscopy time and contrast media usage were not observed in subgroup analysis for the CorPath 200 system compared to M-PCI. Nevertheless, a favorable effect of R-PCI with the CorPath GRX system was evident in relation to these variables.
No studies were identified, whether short or long-term, examining the consequences of radiation exposure or orthopedic injuries associated with coronary procedures.
Authors' methods:
A systematic literature search was conducted in the following reference databases up to May 2023: Medline, EMBASE, Cochrane Library, WOS, ECRI, Inspec and CINAHL. The websites of NICE, CADTH, HIS, HIQA, AHRQ, RedETS and NHS EED, ClinicalTrials.gov, ISRCTN Registry y CEA Registry were also explored. Two independent researchers performed the selection of studies and analyzed their quality. The synthesis of results was carried out both quantitatively and qualitatively. The quality of the studies was assessed using the AMSTAR-2 tools for systematic reviews and ROBINS-I for clinical trials.
Details
Project Status:
Completed
Year Published:
2024
URL for published report:
https://www.aetsa.org/download/02_2022_AETSA_Corindus-Sistema-Robotico_WEB.pdf
English language abstract:
An English language summary is available
Publication Type:
Full HTA
Country:
Spain
DOI:
10.52766/JKUB9876
MeSH Terms
- Coronary Disease
- Percutaneous Coronary Intervention
- Robotic Surgical Procedures
- Heart Diseases
- Cardiac Catheterization
Keywords
- Cardiovascular Diseases
- Catheterization
- Stents
- Cardiovascular Surgical Procedures
- Coronary Angiography
- Robotics
Contact
Organisation Name:
Andalusian Health Technology Assessment Area
Contact Address:
Area de Evaluacion de Tecnologias Sanitarias Sanitarias de Andalucia (AETSA) Avda. Innovación, s/n Edificio Arena 1. Sevilla (Spain) Tel. +34 955 006 309
Contact Name:
aetsa.csalud@juntadeandalucia.es
Contact Email:
aetsa.csalud@juntadeandalucia.es
Copyright:
<p>Andalusian Agency for Health Technology Assessment (AETSA)</p>
This is a bibliographic record of a published health technology assessment from a member of INAHTA or other HTA producer. No evaluation of the quality of this assessment has been made for the HTA database.